NCT05859893

Brief Summary

This study investigated the impact of traditional classical Turkish music as a telehealth intervention on reducing stress and loneliness among elderly individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

May 5, 2023

Last Update Submit

May 15, 2023

Conditions

Keywords

livestreammusictele-medicine

Outcome Measures

Primary Outcomes (4)

  • The Perceived Stress Scale (first evaluation with posttest)

    Scale was developed by Cohen, Kamarck, and Mermelstein (1983), and adapted to Turkish culture by Eskin et al. (2013) to determine the potential effects of sample stress and loneliness perception on sociodemographic and musical tendencies. According to the psychometric adaptation study, criterion validity was ensured, with an internal consistency value of .84 and a test-retest reliability of .87. The scale, which consists of 14 items, is interpreted based on the total score and two sub-dimensions (Inadequate self-efficacy perception-ISPE and stress-discomfort perception-SDP). A high total score indicates a high perception of stress, inadequate coping strategies, and ineffective stress management. In this study, the Cronbach's alpha coefficient of the scale was 0.82.

    Through intervention completion, an average of 1 months

  • The UCLA Loneliness Scale III (first evaluation with posttest)

    Scale is a widely used tool for assessing loneliness, which was developed by Russell et al. (1978). The psychometric properties of the UCLA Loneliness Scale III (UCLA-III) in Turkish culture were first investigated by Demir (1989). In this study, the 3rd revision of the scale developed by Durak and Senol Durak (2010) for Turkish culture was used. The scale consists of 20 items and is rated on a four-point Likert scale (1: Never - 4: Always). The total score ranges from 20 to 80, with higher scores indicating greater loneliness. In similar sample groups, the Cronbach's alpha coefficient of the scale was found to be 0.91, indicating high psychometric suitability (Kurt 2014). In the context of this study, the Chronbach's alpha coefficient of the scale is 0.93.

    Through intervention completion, an average of 1 months

  • The Perceived Stress Scale (second evaluation with follow up)

    Scale was developed by Cohen, Kamarck, and Mermelstein (1983), and adapted to Turkish culture by Eskin et al. (2013) to determine the potential effects of sample stress and loneliness perception on sociodemographic and musical tendencies. According to the psychometric adaptation study, criterion validity was ensured, with an internal consistency value of .84 and a test-retest reliability of .87. The scale, which consists of 14 items, is interpreted based on the total score and two sub-dimensions (Inadequate self-efficacy perception-ISPE and stress-discomfort perception-SDP). A high total score indicates a high perception of stress, inadequate coping strategies, and ineffective stress management. In this study, the Cronbach's alpha coefficient of the scale was 0.82.

    Through intervention completion, an average of 3 months

  • The UCLA Loneliness Scale III (second evaluation with follow up)

    Scale is a widely used tool for assessing loneliness, which was developed by Russell et al. (1978). The psychometric properties of the UCLA Loneliness Scale III (UCLA-III) in Turkish culture were first investigated by Demir (1989). In this study, the 3rd revision of the scale developed by Durak and Senol Durak (2010) for Turkish culture was used. The scale consists of 20 items and is rated on a four-point Likert scale (1: Never - 4: Always). The total score ranges from 20 to 80, with higher scores indicating greater loneliness. In similar sample groups, the Cronbach's alpha coefficient of the scale was found to be 0.91, indicating high psychometric suitability (Kurt 2014). In the context of this study, the Chronbach's alpha coefficient of the scale is 0.93.

    Through intervention completion, an average of 3 months

Study Arms (2)

No Intervention: Control

NO INTERVENTION

Intervention

EXPERIMENTAL

Behavioral: Interactive livestreamed classical Turkish music sessions with a professional music band. The sessions, which lasted approximately one and a half hours, twice a week, have been completed within one month.

Behavioral: Classical Turkish Music Sessions

Interventions

The participants attended an interactive livestreamed music performance. In selecting the mode, tempo, and songs to be performed, recommendations were obtained from the Applied Music Therapies Association, and the pieces with copyrighted recordings presented by the Edirne State Turkish Music Ensemble, under the leadership of the General Directorate of Fine Arts of the Ministry of Culture and Tourism. As part of the project, examples of traditional Turkish songs were presented to the elderly. The recommended genres and songs consist of vocal and instrumental works belonging to major and minor scales from the Classical Period, which spans from the 14th to the 20th century. In this respect an assembly of eight-musican consisting of five artists playing kanun, tanbur, ney, classical kemençe, and bendir, as well as two vocal soloists performed.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Registered for and attending their first years of lectures
  • Aged higher than 65 year
  • Able to use an interactive social media application via a computer, mobile phone or other electronic devices
  • Participate willingly and voluntarily in the research.

You may not qualify if:

  • Have a physical or sensory impairment that would affect the ability to listen to music (e.g., history of temporal brain damage, limb loss, hearing loss, etc.),
  • Have a psychiatric diagnosis that would affect decision-making and orientation assessment abilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Nursing

Izmır, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: The current 4-week randomized, single-blind factorial trial was conducted with a control group and one intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member, lecturer, research associate

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

June 3, 2020

Primary Completion

July 24, 2021

Study Completion

September 15, 2021

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Public data sharing is applicable to this article. It is planned to publish the research results in a high-impact journal in the field.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Approx 1 year after RCT registration.

Locations